Many pharmaceutical compositions containing steroidal anti-flammatory agents are available for topical application. These include ointments, creams, lotions, solutions, etc. See Physician's Desk Reference (PDR) 1976, 30th Edition, Medical Economics Company, New Jersey. In particular, many pharmaceutical ointments containing topical anti-flammatory steroids for topical application are known. For example, triamcinolone acetonide, fluocinonide, fluocinolone acetonide, hydrocrotisone acetate, methylprednisolone acetate, and hydrocortisone. See PDR, supra, pages 872, 1528, 1529, 1569, 1581, and 1194, respectively.
In general, the commercial anti-inflammatory pharmaceutical compositions all contain an anti-inflammatory steroid, which are useful when applied topically, and a pharmaceutical acceptable carrier for applying the anti-inflammatory steroid topically.
U.S. Pat. No. 3,180,797 discloses a pharmaceutical composition containing an anti-inflammatory steroid in an aqueous solution. The pharmaceutical compositions of the present invention contain no water.
U.S. Pat. No. 3,352,753 discloses pharmaceutical compositions for topical application comprising a corticosteroid in a gel form. The present invention does not include gels.
U.S. Pat. No. 3,867,528 discloses a topical cream composition useful for administering anti-inflammatory steroids topically. The cream formulation contains ethoxylated stearyl alcohol, benzyl alcohol, isopropylpalmitate, glycerine, and sorbitol solution. The present invention contains none of these ingredients.
U.S. Pat. Nos. 3,749,773, 3,892,586, 3,892,587, and 3,934,013 all disclose pharmaceutical compositions for administering an anti-inflammatory steroid topically. All four patents disclose the use of the propylene glycol as a solvent for the steroids. U.S. Pat. No. 3,749,773 discloses that the composition has the property of possessing anti-bacterial activity. This is not surprising or unexpected in view of the fact that the composition contains approximately 15% of ethyl alcohol which is known anti-bacterial agent. U.S. Pat. No. 3,892,857 differs from the present invention in that it discloses besides the anti-inflammatory steroid the other major ingredients are propylene glycol and water. The present invention contains no water. The propylene glycol utilized in the four above-identified U.S. patents was used as a solvent to dissolve the steroid. Propylene glycol is known to be a good solvent. However, it also possesses two very undesirable qualities from a pharmacological point of view. These are (1) that it is irritating to the skin and (2) that it is a non-lubricant. Therefore, there is a need to find a solvent which is suitable for dissolving an anti-inflammatory steroid which is non-irritating and which has lubricant properties.
The present invention discloses such a solvent, polyoxypropylene 15 stearyl ether.
Polyoxypropylene 15 stearyl ether is marketed under the trademark Arlamol.RTM. E by Imperial Chemical Industries (ICI) as an emollient solvent for cosmetic products. It is disclosed as being an emollient, a lubricant, and a solvent useful in cosmetic products such as bath oils, sunscreens, hair products, aerosol, anti-perspirants, and hand and body lotions.
There is no disclosure in any manner whatsoever of using polyoxypropylene 15 stearyl ether as a solvent in pharmaceutical preparations with anti-inflammatory steroids for topical administration.